|
Device | COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) |
Generic Name | Cytomegalovirus (cmv) dna quantitative assay |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110037 |
Supplement Number | S027 |
Date Received | 07/08/2016 |
Decision Date | 08/04/2016 |
Product Code |
PAB |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a new fermenter used in the manufacturing process for enzymes. |